Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) With Omnipolar Mapping Technology
NCT ID: NCT06701292
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-01-15
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PVS-PVI
PVS-PVI targeted ablation
Omnipolar technology will be used to analyze all PVs and delineate the PVMS. Once identified, PVMS will be marked and described in a clockface fashion using a lateral view of the vein.Ablation will target the PVMS using the same power and force parameters as described for the WACA procedure. Effective ablation lesions and distance between ablation spots will be represented in the same manner too. Lesions should cover at least 5 mm outside the PVMS delineation on both PVMS borders of each myocardial sleeve. PVI will be demonstrated with the same technique described in the WACA procedure.
The PVI will be verified for each vein 10 minutes after the initial achievement of PVI.
WACA
Wide area circumferential ablation (WACA)
After generating the 3D electroanatomical map of the heart to understand where treatment needs to be applied,using a tool called radiofrequency (RF) ablation, small burns will be made around the veins to block abnormal electrical signals. Each burn is applied with up to 50 watts of power and lasts up to 10 seconds.The ablation tool will press down with a force of around 10-20 grams.The mapping system (NAVX software) shows the burns on the 3D map
Interventions
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PVS-PVI targeted ablation
Omnipolar technology will be used to analyze all PVs and delineate the PVMS. Once identified, PVMS will be marked and described in a clockface fashion using a lateral view of the vein.Ablation will target the PVMS using the same power and force parameters as described for the WACA procedure. Effective ablation lesions and distance between ablation spots will be represented in the same manner too. Lesions should cover at least 5 mm outside the PVMS delineation on both PVMS borders of each myocardial sleeve. PVI will be demonstrated with the same technique described in the WACA procedure.
The PVI will be verified for each vein 10 minutes after the initial achievement of PVI.
Wide area circumferential ablation (WACA)
After generating the 3D electroanatomical map of the heart to understand where treatment needs to be applied,using a tool called radiofrequency (RF) ablation, small burns will be made around the veins to block abnormal electrical signals. Each burn is applied with up to 50 watts of power and lasts up to 10 seconds.The ablation tool will press down with a force of around 10-20 grams.The mapping system (NAVX software) shows the burns on the 3D map
Eligibility Criteria
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Inclusion Criteria
* A minimum of one documented AF episode via 12-lead ECG, Holter monitor, or loop recorder
* Capability to provide informed consent
Exclusion Criteria
* Prior history of catheter or surgical ablation for AF or left atrial ablation for atypical flutter
* Reversible causes of AF
* Congenital heart disease
* Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
* Pregnancy
* Known presence of intracardiac thrombus
* Systemic oral anticoagulation therapy contraindicated, including a history of heparin-induced thrombocytopenia
* Broad vortex-like connections and no clear PVMS to be targeted
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Ramesh Hariharan
Professor
Principal Investigators
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Ramesh Hariharan, D, MRCP,FACC, FHRS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-MS-24-0150
Identifier Type: -
Identifier Source: org_study_id
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